Healthcare Regulatory Affairs Outsourcing Market to Witness Growth due to Rise in research and development activities and requirement of an extensive documentation

According to latest report published by Future Market Insights titled ‘Global Healthcare Regulatory Affairs Outsourcing Market’, global Healthcare Regulatory Affairs Outsourcing market is poised to expand at 12.2 CAGR over the forecast period of 2017–2027.

The global market for Healthcare Regulatory Affairs Outsourcing is expected to exceed US$ 2,541.6 Mn by 2025 end, in terms of value attesting the growth rate of 12.2% over 2017–2025. The Healthcare Regulatory Affairs Outsourcing market in developing countries is expected to witness fast and steady growth due to increasing research and development activities across the world, Increasing cost efficiencies, and Increasing cost efficiencies, Extensive documentation during drug/device and other such factors contribute to the growth of the healthcare regulatory affairs outsourcing market.

By service type, Regulatory Writing and Publishing, service type segment created over 36.2% global revenue in 2016 and will continue to dominate the global market for Healthcare Regulatory Affairs Outsourcing. Development of advanced products, robust clinical pipeline primarily across few European countries and the U.S. is propelling the demand for outsourcing healthcare regulatory affairs market. Increasing R&D Activities Enable Development of New Products, With the increasing austerity measures by the respective regulatory authorities worldwide, an increased collaboration between the drug developers and CROs and CMOs has been observed in order to mitigate the risks. Furthermore, gradually approaching patent expirations of block buster drugs (Humira, Remicade, etc.) mandate the companies to focus on efficient drug discovery processes and cost efficiency. CMOs and CROs have come to rescue of these companies, thereby enabling the pharmaceutical companies to focus on core business activities. Regulatory affairs and operations encompass a wide range of processes such as regulatory data management, country regulatory affairs, report publishing, submission planning, regulatory strategy, dossier conversion, literature searches, and others. Regulatory service providers are constantly refining their service offering strategies in order to ensure increased consistency. For instance, Quintiles employs Hub and Spoke model to serve its clients. Factors such as extensive documentation involved during drug/device manufacturing, increasing preference for outsourcing regulatory affairs along with enhanced cost efficiencies result in increased demand for the regulatory affairs outsourcing activities and drive the market growth. On the other hand, factors such as system access, data security, loss of control, increased compliance risk, and third party performance are some of the concerns that would hamper the market growth

The global Healthcare Regulatory Affairs Outsourcing market has been segmented on the basis of service type, end user and regions. Based on Service type, global Healthcare Regulatory Affairs Outsourcing market has been segmented into Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation and Other Regulatory Affairs. Regulatory Consulting and Legal Representation is the fastest growing segment. In addition, with the increasing use of technological platforms such as software for the clinical data management, content management, database and document management, results in hyped ultimate price for the services offered and this in turn would hamper the market growth. Hence, both the aforementioned factors result in rapid pricing fluctuations which restrains the pharmaceutical companies from outsourcing regulatory activities. The technological advances no doubt improve the overall process but add to the total costs as well.

In terms of value, global Regulatory Writing and Publishing market is expected to expand at 10.8% CAGR over the forecast period of 2017–2025. With nearly 34.7% market share, The APAC healthcare regulatory affairs outsourcing market is expected to grow at the CAGR of 13.2% over the forecast period (2017–2025). Regulatory document submissions, liasioning with regulatory authorities, product labeling, regulatory document submissions are some of the regulatory affair services offered by CROs to the pharmaceutical and biotechnology companies. North America was the leading market for regulatory affairs outsourcing in 2015, owing to the increasing number of clinical trials and rigorous R&D activities conducted by several large pharmaceutical companies in the region. Europe is expected to the third largest market for Healthcare Regulatory Affairs Outsourcing. According to the data published by the R&D magazine focusing on the global R&D Funding Forecast (2016), estimated that the investment by Asian countries held the leading position for R&D spending as compared to North America and European countries. In 2015, R&D spending by North America accounted for around 28.5%, Europe accounted for 21.3% share of the total R&D spending, while Asia accounted for 41.2.%. The below table highlights the share of the total global R&D spending by leading regions

Key Research Findings

Healthcare Regulatory Affairs Outsourcing segment, Regulatory Writing and Publishing accounted for major value due to extensive documentation involved during drug/device manufacturing. The share of the regulatory writing and publishing to be outsourced are high in developed countries compared to developing countries due to excessive research and development activities.

Consistent evaluation of cost-saving options such as regulatory affairs outsourcing and contract manufacturing organizations (CMOs) is carried out by several drug/device manufacturers in order to streamline their operations and ensure the product safety and maintain the public healthcare

By End User, the Mid-Size Pharmaceutical Companies represents absolute $ opportunity of US$ 32.6 Mn in 2018 over 2017 and incremental opportunity of US$ 489.6 Mn between 2017 and 2025

CROs must focus on personal value or value-added offerings in order to fulfil the need for differentiation. CROs who can win the battle for differentiation would sustain the growing competitive pressure in the future. Emerging trends such as increasing product pipeline, awareness about IPR and related issues, focusing on understanding business model, data safety, development of transition plans, regulatory changes etc. provides considerable opportunities to CROs that can offer these solution differentiate themselves from traditional CROs.

Sabyasachi Ghosh is an experienced market research analyst and consultant, with over six years of experience in end-to-end project management. He has worked at numerous leadership positions and has a vast experience of compiling high-quality market research reports. Sabyasachi is an authoritative voice in the market research sector, and has been cited in top industry publications. He is a travel junkie, and loves to travel far and wide with his friends.